PCXX NEUTRAL GEL PINA COLADA

Manufacturer: Ross Healthcare Inc.
Effective date: 2014-05-21
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:18:49

Label at a glance#

ProductPCXX NEUTRAL GEL PINA COLADA

Active ingredientSODIUM FLUORIDE

Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCXX NEUTRAL PC FRONT PANEL

WARNINGS AND PRECAUTIONS SECTION

PCXX NEUTRAL PC SECONDARY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62007-024-16	2020-01-31	C162847	48780-1	9d75b9d0-ffeb-f424-e053-dadaa90a57ce	ee5aa0d9-5007-46ab-bc47-e1594a1285e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62007-024-16	PCXX NEUTRAL GEL PINA COLADA	1 mg in 1 BOTTLE, PLASTIC	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-024	PCXX NEUTRAL GEL PINA COLADA (FLUORIDE TREATMENT) GEL [ROSS HEALTHCARE INC.]	1	Legacy NDC, 1 package rows	20140530_ee5aa0d9-5007-46ab-bc47-e1594a1285e7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

PCXX NEUTRAL GEL PINA COLADA
FLUORIDE TREATMENT
SODIUM FLUORIDE
FLUORIDE ION
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62007-024	62007-024-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
FD&C YELLOW NO. 5	I753WB2F1M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
047d7981-a94f-4b01-a8c2-46d76b96aede			ee5aa0d9-5007-46ab-bc47-e1594a1285e7	2014-05-21	Warnings	Exact identifier spl id: 047d7981-a94f-4b01-a8c2-46d76b96aede spl set id: ee5aa0d9-5007-46ab-bc47-e1594a1285e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.